Peritoneal dialysate fluid generation system with integrated cycler

Abstract

Systems and methods of generating peritoneal dialysate and using the peritoneal dialysate with an integrated cycler are provided. The systems and methods use a water purification module, a sterilization module and concentrates to prepare peritoneal dialysate from source water and infuse the prepared peritoneal dialysate into a patient with an integrated cycler. Optional dialysate storage containers are provided for storage of the peritoneal dialysate prior to use.

1 . A system, comprising:
 a water source;   a peritoneal dialysate generation flow path; wherein the peritoneal dialysate generation flow path is fluidly connectable to the water source;   one or more water purification modules fluidly connectable to the peritoneal dialysate generation flow path;   a concentrate source fluidly connectable to the peritoneal dialysate generation flow path;   the concentrate source containing one or more solutes;   a sterilization module fluidly connectable to the peritoneal dialysate generation flow path; and   an integrated cycler fluidly connected to the peritoneal dialysate generation flow path.   
     
     
         2 . The system of  claim 1 , further comprising one or more dialysate containers fluidly connectable to the peritoneal dialysate generation flow path downstream of the sterilization module. 
     
     
         3 . (canceled) 
     
     
         4 . (canceled) 
     
     
         5 . The system of  claim 1 , wherein the concentrate source comprises a single source containing at least one osmotic agent and at least one ion concentrate; multiple osmotic agent sources; and/or multiple ion concentrate sources. 
     
     
         6 . The system of  claim 5 , wherein the osmotic agent sources contain osmotic agents selected from the group consisting of dextrose, icodextrin, amino acids, and glucose; and wherein the ion concentrate source comprises one or more from the group consisting of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate. 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The system of  claim 1 , further comprising a control system for controlling one or more pumps and valves to control movement of fluid through the system; wherein the control system either (a) comprises a timer, wherein the timer causes the control system to generate peritoneal dialysate at a predetermined time; and/or (b) comprises a user interface, wherein the user interface causes the control system to generate peritoneal dialysate at a selected time. 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . The system of  claim 1 , wherein the sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a heater, a flash pasteurization module, a microbial filter, and combinations thereof. 
     
     
         14 . The system  claim 13 , wherein the sterilization module comprises either or both of: the UV light source positioned downstream of the ultrafilter; and/or at least two ultrafilters. 
     
     
         15 . The system of  claim 1 , wherein the water purification module comprises one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter, and a nanofilter. 
     
     
         16 . The system of  claim 1 , wherein the integrated cycler comprises a heater, a pump, an infusion line, and a drain line. 
     
     
         17 . The system of  claim 16 , wherein the integrated cycler further comprises at least one sensor selected from the group consisting of a flow meter, a pressure sensor, a conductivity sensor, and a temperature sensor. 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . The system of  claim 16 , wherein the integrated cycler further comprises a filter in the infusion line. 
     
     
         22 . A method, comprising the steps of:
 pumping fluid from a water source to a water purification module in a peritoneal dialysate generation flow path;   adding one or more concentrate solutions to the fluid;   pumping the fluid through a sterilization module;   heating the fluid; and   pumping the fluid into a peritoneal cavity of a patient with an integrated cycler.   
     
     
         23 . The method of  claim 22 , further comprising the step of pumping the fluid into one or more dialysate containers and pumping the fluid from the one or more dialysate containers into the peritoneal cavity of the patient. 
     
     
         24 . The method of  claim 22 , wherein the step of adding one or more concentrate solutions to the fluid comprises adding at least an osmotic agent and an ion concentrate to the fluid; wherein the osmotic agent and ion concentrate are added to the fluid from a single concentrate source; or wherein the osmotic agent and ion concentrate are added from separate concentrate sources. 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . The method of  claim 24 , wherein the osmotic agent is one or more selected from the group consisting of glucose, dextrin, and icodextrin; and wherein the ion concentrate is added from one or more ion concentrate sources and comprises one or more from the group consisting of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate. 
     
     
         28 . The method of  claim 24 , wherein the osmotic agent comprises multiple osmotic agents; and wherein the multiple osmotic agents are added from a single osmotic agent source; or wherein multiple osmotic agents are added from separate osmotic agent sources. 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . The method of  claim 24 , wherein each of the ion concentrates are added to the fluid from a single ion concentrate source; or wherein the ion concentrate source comprises multiple ion concentrate sources; and wherein each of the multiple ion concentrate sources comprise different solutes. 
     
     
         33 . (canceled) 
     
     
         34 . (canceled) 
     
     
         35 . The method of  claim 22 , wherein the method is carried out by a peritoneal dialysate generation system; wherein (a) the peritoneal dialysate generation system comprises a timer and the peritoneal dialysate generation system carries out the method at predetermined times; and/or (b) the peritoneal dialysate generation system comprises a user interface, and the method is carried out based on input from the user interface. 
     
     
         36 . (canceled) 
     
     
         37 . (canceled) 
     
     
         38 . The method of  claim 22 , wherein the water purification module comprises one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter and a nanofilter. 
     
     
         39 . The method of  claim 22 , wherein the sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a microbial filter, and combinations thereof. 
     
     
         40 . (canceled)